Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT05134259
Eligibility Criteria:
Inclusion Criteria:
1. Willingness to participate.
2. Age group between 4 and 18 years.
3. They are able to walk with limitation or holding on according to Gross Motor Function classification System (GMFCS) (level II, III, IV).
4. All patients have mild to moderate spasticity according to modified Ashworth scale (Grade 1, 1+,2).
Exclusion Criteria:
* All Children with:
1. Perceptual defects (IQ\<70).
2. Use of botulinum toxin in the past 4 months.
3. Convulsions.
4. Other peripheral or central nervous system dysfunction.
5. Fixed deformities in lower limbs.
6. Clinically suspected active inflammatory or pathologic changes in lower limb joints during the previous 6 months.
7. Clinically suspected active medical problems, such as pneumonia, meningitis, encephalitis, upper gastrointestinal bleeding, or urinary tract infection.
8. Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders.
9. Metallic implants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT05134259
Study Brief:
Protocol Section:
NCT05134259